NCT04205734

Brief Summary

There are currently no serum levels to help guide appropriate methotrexate therapy. Data from this study will assess the correlation between dosing and whole blood methotrexate(MTX) polyglutamate measurements in children and adolescents with IBD.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 30, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

3.9 years

First QC Date

September 17, 2019

Last Update Submit

October 8, 2023

Conditions

IBD

Outcome Measures

Primary Outcomes (1)

  • Methotrexate Polyglutamate Level

    Measurement of Methotrexate Polyglutamate Levels

    Samples will collected within 16 weeks of consent.

Secondary Outcomes (2)

  • The correlation between Methotrexate Polyglutamate Levels and Lab Parameters

    Samples will collected within 16 weeks of consent.

  • The correlation between Methotrexate Polyglutamate Levels and Clinical History

    Samples will collected within 16 weeks of consent.

Interventions

MTX AssessmentDIAGNOSTIC_TEST

Measurement of Methotrexate Polyglutamate levels.

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with IBD being treated with methotrexate (oral or subcutaneous)

You may qualify if:

  • IBD
  • Methotrexate Therapy

You may not qualify if:

  • Inability to provide relevant samples

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

5 ml of whole blood

Study Officials

  • PAUL A RUFO

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

September 17, 2019

First Posted

December 19, 2019

Study Start

January 30, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations

US(1)